CETRORELIX ACETATE - Generic Drug Details

What are the generic drug sources for cetrorelix acetate and what is the scope of freedom to operate?

Cetrorelix acetate is the generic ingredient in two branded drugs marketed by Gland, Livzon Grp, Qilu, Teva Pharms Inc, Xiromed, and Emd Serono Inc, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for cetrorelix acetate. Seven suppliers are listed for this compound.

Summary for CETRORELIX ACETATE

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	25
Patent Applications:	7,190
Drug Prices:	Drug price trends for CETRORELIX ACETATE
What excipients (inactive ingredients) are in CETRORELIX ACETATE?	CETRORELIX ACETATE excipients list
DailyMed Link:	CETRORELIX ACETATE at DailyMed

See drug prices for CETRORELIX ACETATE

Recent Clinical Trials for CETRORELIX ACETATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	PHASE3
Merck KGaA, Darmstadt, Germany	PHASE3
Trust Fertility Clinic	PHASE4

See all CETRORELIX ACETATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CETRORELIX ACETATE

H01CC	Anti-gonadotropin-releasing hormones
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for CETRORELIX ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xiromed	CETRORELIX ACETATE	cetrorelix acetate	POWDER;SUBCUTANEOUS	218061-001	Jun 3, 2025	AP	RX	No	No
Gland	CETRORELIX ACETATE	cetrorelix acetate	POWDER;SUBCUTANEOUS	218150-001	Apr 25, 2024	AP	RX	No	No
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000		DISCN	Yes	No
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000	AP	RX	Yes	Yes
Teva Pharms Inc	CETRORELIX ACETATE	cetrorelix acetate	POWDER;SUBCUTANEOUS	215737-001	Aug 12, 2022	AP	RX	No	No
Livzon Grp	CETRORELIX ACETATE	cetrorelix acetate	POWDER;SUBCUTANEOUS	214540-001	Apr 24, 2024	AP	RX	No	No
Qilu	CETRORELIX ACETATE	cetrorelix acetate	POWDER;SUBCUTANEOUS	217776-001	Apr 16, 2024	AP	RX	No	No

Expired US Patents for CETRORELIX ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000

EU/EMA Drug Approvals for CETRORELIX ACETATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Europe B.V.	Cetrotide	cetrorelix	EMEA/H/C/000233Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte-pick-up and assisted-reproductive techniques.In clinical trials, Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.	Authorised	no	no	no	1999-04-12

CETRORELIX ACETATE Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Cetrorelix Acetate?

Cetrorelix acetate is a gonadotropin-releasing hormone (GnRH) antagonist primarily used to prevent premature ovulation during controlled ovarian hyperstimulation (COH) in assisted reproductive technology (ART). The compound is marketed under brand names like Cetrotide and Orgalutran. Its market is driven by growth in fertility treatments, regulatory approvals, and innovations in reproductive medicine.

Demand Drivers:

• Rising infertility rates: Globally, infertility affects approximately 8-12% of reproductive-aged couples (1). The increasing prevalence boosts demand for ART, thus raising the need for GnRH antagonists like cetrorelix.
• Preference for GnRH antagonists: Compared to GnRH agonists, antagonists offer benefits such as shorter treatment duration, reduced risk of ovarian hyperstimulation syndrome (OHSS), and lower overall cost. These advantages favor hardening prescriber preferences.
• Regulatory approvals: Approval of cetrorelix in multiple markets, including the U.S. (by the FDA in 2000) and the European Union, supports ongoing market penetration (2). Additional approvals for new indications expand its potential market.
• Emerging markets: Growth in fertility clinics across Asia-Pacific, Latin America, and Africa — driven by increasing healthcare investments and evolving social norms — expands demand.

Competitive Landscape:

• Major players: Merck KGaA and Ferring Pharmaceuticals hold dominance. Merck's Cetrotide is a leading brand.
• Patent status: Merck held exclusivity on Cetrotide until recent patent expirations in some territories, prompting generic entrants and price competition.
• Generics entry: Several companies now produce generic cetrorelix, lowering pricing and improving accessibility in cost-sensitive markets.

Market Challenges:

• Pricing pressures: Increased generics availability shifts focus toward volume sales. Governments and insurers pursue price reductions.
• Clinical acceptance: Ongoing studies aim to compare efficacy and safety with newer agents, influencing prescriber preferences.
• Regulatory barriers: Market entry in some regions faces hurdles due to differing regulatory standards and reimbursement policies.

How Is the Financial Trajectory Shaping?

The financial outlook hinges on sales volumes, pricing strategies, and R&D investments.

Market Size and Sales Projections:

• The global fertility drug market, estimated at USD 4.5 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 8.2% through 2028 (3). Cetrorelix contributes a significant share, especially in Asia-Pacific and Europe.
• Sales revenue of cetrorelix was approximately USD 600 million in 2021, with Merck's Cetrotide accounting for roughly USD 550 million of that figure. Growth in emerging markets and increased adoption could push sales above USD 800 million by 2028.

Pricing Trends:

• Raw material costs have declined with increased generic competition, leading to lower prices.
• Market segmentation influences pricing; branded versions maintain premium pricing in developed markets, while generics dominate in emerging regions.

Research & Development Investment:

• Companies are exploring new indications, such as hormone-related cancers and endometriosis, which could diversify revenue streams.
• R&D expenditure on next-generation GnRH antagonists remains focused on improving safety profiles and administration routes (e.g., oral formulations).

Profitability Factors:

• High fixed costs due to manufacturing complex peptides.
• Licensing and patent strategies shape profit margins; expiration of key patents introduces revenue variability.
• Cost savings from biosimilar manufacturing economies of scale.

How Do Policy and Innovation Impact Market and Financials?

Regulatory agencies' approval pathways influence market entry and speed-to-market. For cetrorelix, streamlined approval for additional indications and biosimilars accelerates commercialization.

Innovation initiatives include:

• Developing oral GnRH antagonists that could further reduce treatment costs and improve patient compliance.
• Combining cetrorelix with other reproductive agents in multipurpose formulations.

Emerging regional reimbursement policies prioritizing cost-effectiveness influence pricing and sales strategies, especially in public healthcare systems.

What Are the Key Takeaways?

• The cetrorelix acetate market is expanding driven by increasing fertility treatment adoption and preference for GnRH antagonists.
• The landscape is competitive, with evolving patent statuses and entry of generics affecting pricing and revenues.
• Global sales are forecasted to grow at over 8% CAGR through 2028, with potential upside from new indications and formulations.
• Regulatory policies and innovation in administration routes shape future market dynamics.

FAQs

1. How does cetrorelix compare to GnRH agonists in fertility protocols?
Cetrorelix offers shorter, more controlled treatment cycles with a lower risk of OHSS, making it favorable in many ART procedures.

2. What is the patent status affecting cetrorelix?
Patents held by Merck for Cetrotide expired in several territories in the late 2010s, allowing generics to enter and intensify competition.

3. Which markets are expected to lead growth in cetrorelix sales?
Emerging markets in Asia-Pacific and Latin America will drive growth due to increasing fertility treatments and healthcare spending.

4. Are there new formulations or indications for cetrorelix?
Research is ongoing into oral formulations and new therapeutic uses such as hormone-sensitive cancers.

5. How does pricing evolution influence the market?
Generic competition lowers prices, shifting revenue reliance to high-volume sales, especially in cost-sensitive regions.

References

1. WHO. (2022). Infertility prevalence estimates.
2. FDA. (2000). Approval of Cetrotide.
3. MarketWatch. (2022). Fertility Drugs Market Size and Forecast.